BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 5012189 · Received August 18, 2015

    Report

    Report Number
    3004753838-2015-75696
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    July 30, 2015
    Report Date
    July 30, 2015
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SUBSEQUENT TO THE INITIAL MDR, THE COMPLAINT SENSOR WAS NOT RETURNED TO DEXCOM. THE PEDIATRIC SHARE RECEIVER (PART NUMBER STK-PR-001/SERIAL NUMBER (B)(4)/LOT NUMBER 5201389), BEING USED WITH THE COMPLAINT SENSOR, WAS RETURNED ON (B)(6) 2015. THE RETURNED RECEIVER WAS VISUALLY INSPECTED AND NO DEFECT WAS FOUND. FUNCTIONAL TESTING WAS PERFORMED AND THE REPORTED FAULT COULD NOT BE REPRODUCED AND THERE WAS NO FAILURE DETECTED. THE DEVICE WAS DETERMINED TO BE OPERATING WITHIN THE REQUIRED SPECIFICATIONS WITHOUT MALFUNCTION; HOWEVER, A REVIEW OF THE DIAGNOSTIC CHART CONFIRMED THE REPORTED EVENT OF INACCURACIES. A ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE SENSOR WAS INSERTED INTO THE ARM. THE DEXCOM G4® PLATINUM (PEDIATRIC) CONTINUOUS GLUCOSE MONITORING SYSTEM USER'S GUIDE STATES: DO NOT INSERT THE SENSOR IN SITES OTHER THAN THE BELLY (ABDOMEN) OR UPPER BUTTOCKS. USE IN OTHER SITES MIGHT CAUSE SENSOR GLUCOSE READINGS TO BE INACCURATE AND COULD RESULT IN YOU MISSING SEVERE HYPOGLYCEMIA (LOW BLOOD GLUCOSE) OR HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) EVENTS.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CONTACTED DEXCOM TECHNICAL SUPPORT ON (B)(6) 2015 TO REPORT CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES COMPARED TO BLOOD GLUCOSE (BG) METER THAT OCCURRED ON (B)(6) 2015. SENSOR WAS INSERTED ON (B)(6) 2015 INTO THE ARM. AT THE TIME OF CONTACT, NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545667 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM MDS MDS DEXCOM, INC. 9500-27 5199104 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR